Fecal Microbiota Transplantation for Kidney Cancer
(PERFORM Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on systemic steroid therapy or antibiotics before the trial. It's best to discuss your specific medications with the trial team.
Is fecal microbiota transplantation (FMT) safe for humans?
Fecal microbiota transplantation (FMT) is generally considered safe and well-tolerated, even in high-risk patients, with most short-term risks being mild and related to delivery methods. However, long-term side effects are not well-established, and serious adverse events have been linked to inadequate screening for multi-drug resistant organisms in some stool banks.12345
How is fecal microbiota transplantation different from other treatments for kidney cancer?
Fecal microbiota transplantation (FMT) is unique because it involves transferring healthy gut bacteria from a donor to a patient to restore the balance of microorganisms in the gut, which may influence the body's immune response and metabolism. Unlike traditional cancer treatments like chemotherapy or radiation, FMT focuses on altering the gut microbiome to potentially impact cancer and its complications.678910
What is the purpose of this trial?
Cancer immunotherapy has been largely adopted in oncology patient management in the last decade. The deep and long responses to immunotherapy have accelerated the approval of these drugs across multiple disease sites. However, these agents can also be toxic to patients, meaning, the patient will have to discontinue treatment and outcomes could be negatively affected. Recently, a combination of two immunotherapy drugs, ipilimumab and nivolumab (ipi/nivo), has been approved for the treatment of intermediate and poor-risk renal cell carcinoma (RCC) patients. This powerful combination provides survival benefit, however, it can also be highly toxic leading to discontinuation of this treatment.There has been some evidence that these otherwise toxic drugs can be better tolerated by altering the composition of the patients gut bacteria to create a more diverse and healthy microbiome. The current study will involve Fecal Microbiota Transplantation (FMT) before the start of the immunotherapy combination, and during the first two cycles of ipilimumab treatment (the more toxic agent) as supportive therapy to prevent toxicity associated with the ipi/nivo combination.The goal of this project is to study the safety of such FMT combination treatment and reduce occurrence of immune-related toxicities in patients, allowing them to continue their cancer treatments in the hopes of a better outcome. The investigators will also be looking at changes in the immune populations, microbiome profile of patients, response to treatment, and patient survival as secondary objectives.
Research Team
Ricardo Fernandes, MD
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Saman Maleki, PhD
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Eligibility Criteria
This trial is for adults with advanced or metastatic renal cell carcinoma, specifically those at intermediate or poor risk. Participants must be in good physical condition (KPS ≥70%), able to swallow capsules, and have not had certain prior treatments including systemic therapy for RCC. Pregnant individuals, those with immunodeficiency, chronic intestinal diseases, active infections requiring systemic therapy, or a history of serious autoimmune disease are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Fecal Microbiota Transplantation
Participants receive Fecal Microbiota Transplantation before the start of immunotherapy and during the first two cycles of ipilimumab treatment
Immunotherapy Treatment
Participants receive combination treatment with ipilimumab and nivolumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fecal Microbiota Transplantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Lawson Health Research Institute
Lead Sponsor
Academic Medical Organization of Southwestern Ontario
Collaborator